FDA-Device2016-06-01Class II
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.)
Hazard
Potential for a product defect where the cannula may be obstructed. This obstruction could prevent a driver from going through, which increases the potential for the driver to slip, resulting in possible patient injury.
Sold states
US nationwide distribution in CA, FL, IN, MI, MO, NC, NY, and TX.
Affected count
17 devices
Manufactured in
375 River Park Cir, N/A, Marquette, MI, United States
Products
Streamline OCT Occipito-Cervico-Thoracic System, Crosslink Counter Torque Sleeve. Spinal fixation device instrument.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1829-2016Don't want to check this manually?
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